01.02.2012

TiGenix rheumatoid arthritis Phase IIa study opens third and last cohort.

Leuven (BELGIUM), Madrid (SPAIN) – February 1, 2012 – TiGenix (NYSE Euronext: TIG) announced today that upon review of the safety data of the first three patients of the second cohort of the company’s Phase IIa clinical trial in rheumatoid arthritis (Cx611) it has received the go-ahead from the independent Safety Monitoring Board to recruit and dose the remaining 20 patients of this cohort and to open the third and final cohort. The Phase IIa
trial is based on a three-step dose-finding protocol, where each step starts with a safety review of the first three patients after 40 days of dosing.

“We are very pleased with reaching the next stage in this Phase IIa trial on schedule,” said Eduardo Bravo, CEO of TiGenix. “With each positive step forward that we take, in addition to promising results recently reported by other companies and research groups in the stem cell field, we are moving closer to the moment that stem cell therapies will be a mainstay of clinical practice, providing solutions for a wide range of unmet medical needs.”

About Cx611 for rheumatoid arthritis
Cx611 is a suspension of expanded allogeneic adult stem cell product derived from human adipose (fat) tissue (expanded Adipose derived Stem Cells or ‘eASCs’) that is delivered through intra-venous injection for the treatment of rheumatoid arthritis. The objective of the Phase IIa trial is to determine safety, feasibility, tolerance, and optimal dosing. This multicentre, placebo-controlled study will involve approximately 53 patients, divided in 3 cohorts with different dosing regimens. There are more than 20 centres open and the company expects the final results to be available in the first half of 2013.

For more information:
Eduardo Bravo
Chief Executive Officer
eduardo.bravo@tigenix.com

Gil Beyen
Chief Business Officer
gil.beyen@tigenix.com

Hans Herklots
Director Investor & Media Relations
hans.herklots@tigenix.com
+32 16 39 79 73

About TiGenix

TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with two marketed products for cartilage repair, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of
Leuven (Belgium) and has operations in Madrid (Spain), Cambridge (UK) and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.

Forward-looking information
This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix’ control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix’ expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.


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